Central Venous Access Device Removal in Cancer Patients

Oncology Clinical Trial

Official title:

Frequency of Central Venous Port Catheter Removal Due to Suspected Infection in Patients Diagnosed With Cancer at a Single Institution: A Retrospective Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03855969
• Other study ID #: AZGS2018106
• Status: Completed
• Start date: March 1, 2019
• Est. completion date: December 30, 2019

Study information

• Verified date: August 2020
• Source: General Hospital Groeninge
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Background:

Central venous catheters are frequently used during cancer treatment with the aim of venepreservation. It can facilitate venous access for the safe administration of irritating or vesicant intravenous cancer medications and / or other fluids, to collect blood samples or to ensure accurate venous access for contrast during medical imaging. In addition, this means more comfort for the patient who needs to be punctured less peripherally. However, central venous catheters can also be a source of bloodstream infections and other complications, leading to increased morbidity and hospital costs (1). In our hospital, there is a general practice that if an infection of the device is suspected, the central venous catheter should be removed if antibiotics do not seem or prove to be effective.

The objective of this trial is to assess the frequency of implanted port catheter-removal in cancer patients due to suspected infection of the device in a particular oncology center over a time period of seven years. Furthermore, evidence for real device infections (per/post-surgery) and the potential contribution of different (institution-specific) risk factors on device infection will be explored. There will be focused on implanted port catheters only, as this is the main used central venous access device within the oncological population.

Trial objectives:

The primary aim of this retrospective descriptive trial is to evaluate the frequency of implanted port catheter-removal in cancer patients due to suspected infection of the device, over a time period of seven years.

The secondary aim is to examine whether the device infection could be confirmed during or after removal of the device.

At last, the tertiary aim is to verify whether certain variables can be denoted as potential risk factors for central venous access infection. Selection of those variables of interest will be based on a thorough review of the literature and discussion with the responsible healthcare professionals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1402
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Central venous access device removal in our general hospital

• Cancer patient

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Haematological Malignancy
• Hematologic Neoplasms
• Neoplasms
• Oncology

Intervention

Procedure:
• Removal of a central venous access device
We are interested in those patients for which a central venous access device was removed.

Locations

Country	Name	City	State
Belgium	GHGroeninge	Kortrijk

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital Groeninge

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Suspected infection rate	How many central venous access devices are removed due to a suspected infection of the device in cancer patients.	2012-2017
Secondary	Approved infection rate	For how many of the central venous access devices that were removed due to suspected infection of the device could an infection be confirmed?	2012-2017
Secondary	Risk factors for central venous access device infections in cancer patients	Is it possible to denote certain variables as potential risk factors for central venous access device infection?	2012-2017